Use of Noninvasive Brain Stimulation in Parkinson's Disease

Spaulding Rehabilitation Hospital12 enrolled

Overview

The purpose of this research is to determine whether repetitive sessions of transcranial direct current stimulation (tDCS) to the prefrontal cortex can enhance the cognitive, affective and motor functioning of those with Parkinson's Disease. In this study we will compare active tDCS with sham tDCS. Each subject will receive two consecutive weeks of stimulation (Monday through Friday). A battery of neuropsychological and affective tests will be administered throughout the duration of the study.

Note that this study is a two-center study (the other center is Beth Israel Deaconess Medical Center - PI - Alvaro Pascual-Leone) \* Further study details are provided by Spaulding Rehabilitation Hospital.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Parkinson's Disease

Interventions

Transcranial direct current stimulationDEVICE

Subjects will receive a total of 10 stimulation sessions on consecutive days, Monday- Friday for a total of two weeks. During each session, 2 mA of tDCS will be applied for 20 minutes over the left or right DLPFC (active or sham).

Eligibility

Sex: ALLMin age: 40 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of "probable" PD, defined by the presence of at least 2 out of 3 cardinal motor features of PD (resting tremor, rigidity, and bradykinesia, plus a sustained and significant response to dopaminergic treatment); * Age 40 or over; * Taking stable medications for at least 30 days Exclusion Criteria: * Features suggestive of other causes of parkinsonism/ parkinson-plus syndromes; * History of deep brain stimulation or ablation surgery, mass brain lesions; * History of schizophrenia, schizoaffective disorder, other psychosis, bipolar illness, alcohol/drug abuse within the past year; * Need for rapid clinical response due to conditions such as initiation, psychosis, or suicidality; * Contraindications to tDCS\* * metal in the head * implanted brain medical devices * Unstable medical conditions (eg. uncontrolled diabetes, uncompensated cardiac issues heart failure, pulmonary issues, or chronic obstructive pulmonary disease) * Pregnancy

Locations (2)

Spaulding Rehabilitation Hospital

Boston, Massachusetts, United States

Berenson Allen Center for Noninvasive Brain Stimulation

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Evidence of improvement in general motor functioning in patients with Parkinson's.

Measured by various indexes, including Unified Parkinson's Disease Rating Scale (UPDRS), Simple Reaction Time, 4-Choice Reaction Time, Purdue Pegboard Test, Finger tapping, walking time, buttoning up and supination-pronation.

Time frame: after treatment (10 days) and at follow up (1 and 2 months after final stimulation)

Secondary Outcomes

Evidence of improvement in cognitive functioning in the areas of: executive function, reasoning, visuospatial ability, and working memory for patients with Parkinson's.

Will be measured by The Stroop Test, Hooper Visual Organization Test, Digit Span Test, Trail Making Test B.

Time frame: after treatment (10 days) and at follow up (1 and 2 months after final stimulation)

Data from ClinicalTrials.gov

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